Duns Number:879187821
Device Description: REDICAPRONE PRO VIO MF 1 YCT-1 36"
Catalog Number
MS347-M
Brand Name
RELI®
Version/Model Number
MS347-M
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172659,K172659,K172659
Product Code
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
81c51c43-dae3-479c-b981-e4ab6cc293ad
Public Version Date
February 05, 2021
Public Version Number
3
DI Record Publish Date
May 13, 2019
Package DI Number
20386120009548
Quantity per Package
30
Contains DI Package
10386120009541
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 7 |
2 | A medical device with a moderate to high risk that requires special controls. | 471 |